FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Agnes
K Number: K223805
·
Decision May 4, 2023
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
7
Review Days
136
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Basic Information
- Device Name
- Agnes
- K Number
- K223805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agnes Medical Co., Ltd.
- Date Received
- December 19, 2022
- Decision Date
- May 4, 2023
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Agnes Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250217 | AGNES Ultra | Sep 3, 2025 | Substantially Equivalent |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) | Aug 19, 2025 | Substantially Equivalent |
| K242469 | RFMagik Lite | Apr 25, 2025 | Substantially Equivalent |
| K230837 | PlazMagik | Feb 29, 2024 | Substantially Equivalent |
| K203013 | AGNES | Jul 14, 2022 | Substantially Equivalent |
| K192728 | Agnes | Oct 24, 2019 | Substantially Equivalent |